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MAVYRET™ (glecaprevir and pibrentasvir) tablets are a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MAVYRET?Hepatitis B virus reactivation: Before starting treatment with MAVYRET, your doctor will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment for hepatitis C virus with MAVYRET. Hepatitis B virus that becomes active again (called reactivation) may cause serious liver problems including liver failure and death. Your doctor will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking MAVYRET.

Do not take MAVYRET if you:

Have certain liver problems

Are taking the medicines:

atazanavir

rifampin

What should I tell my doctor before taking MAVYRET?

If you have had hepatitis B virus infection, have liver problems other than hep C infection, have HIV-1 infection, have had a liver or a kidney transplant, or any other medical conditions.

If you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAVYRET.

About all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause you to have too much or not enough MAVYRET or other medicines in your body. This may affect the way MAVYRET or your other medicines work, or may cause side effects.

Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take MAVYRET with other medicines.

What are the common side effects of MAVYRET?

The most common side effects of MAVYRET are headache and tiredness.

These are not all of the possible side effects of MAVYRET. Tell your doctor if you have any side effect that bothers you or that does not go away.

This is the most important information to know about MAVYRET. For more information, talk to your doctor or healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.

If you cannot afford your medication, contact www.pparx.org for assistance.

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including Important Warning on Hepatitis B reactivation.

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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MAVYRET?Hepatitis B virus reactivation: Before starting treatment with MAVYRET, your doctor will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment for hepatitis C virus with MAVYRET. Hepatitis B virus that becomes active again (called reactivation) may cause serious liver problems including liver failure and death. Your doctor will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking MAVYRET.

Do not take MAVYRET if you:

Have certain liver problems

Are taking the medicines:

atazanavir

rifampin

What should I tell my doctor before taking MAVYRET?

If you have had hepatitis B virus infection, have liver problems other than hep C infection, have HIV-1 infection, have had a liver or a kidney transplant, or any other medical conditions.

If you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if MAVYRET will harm your unborn baby or pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAVYRET.

About all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause you to have too much or not enough MAVYRET or other medicines in your body. This may affect the way MAVYRET or your other medicines work, or may cause side effects.

Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take MAVYRET with other medicines.

What are the common side effects of MAVYRET?

The most common side effects of MAVYRET are headache and tiredness.

These are not all of the possible side effects of MAVYRET. Tell your doctor if you have any side effect that bothers you or that does not go away.

This is the most important information to know about MAVYRET. For more information, talk to your doctor or healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.